Redefining Access to Innovative Epilepsy Solutions

A Market Access Journey

The 2nd Monday in February is International Epilepsy Day. On this day we stand in solidarity with those impacted by epilepsy, recognizing the challenges they regularly face, and the pivotal role of advancements made in medical technology, succeeding to improve their quality of life.

At inspiring-health we're committed to ensuring that groundbreaking medical technologies reach those who need them most. Our focus on Market Access isn't just about navigating regulatory landscapes; it's about bridging the gap between innovation and patient care.

Did you know that epilepsy affects approximately 50-90 individuals per 10,000 people in Germany alone, with a prevalence of 5–9/1,000 in industrialized nations? Furthermore, in a study by Aletsee (2011), the direct and indirect costs of active epilepsy in Germany were found to average €2,550 ± 4,200 per patient over just three months, potentially exceeding €10,000 annually. These figures underscore the substantial economic burdens on healthcare systems due to hospitalizations, medications, and lost productivity.

In our recent collaboration with a medical device manufacturer, we encountered a familiar hurdle: the struggle to secure reimbursement for a novel diagnostic device, in this case aimed at revolutionizing epilepsy management. Despite previous attempts, regulatory responses failed to acknowledge the device's novelty and innovation. Limited transparency in the reimbursement process emerges as a notable barrier for innovative technologies, hindering patient access.

Through our partnership, we embarked on a strategic approach, navigating the complexities of the regulatory landscape to ensure that the groundbreaking potential of this technology doesn't go unnoticed. Our latest endeavor involves submitting a § 137e application, complemented by a meticulously planned study to demonstrate the efficacy, potential and value of the device.

The planned multi centers study seeks to showcase superiority of the novel device compared to traditional patient diaries. In quantifying the impact and differentiation of the technology, we pave the way for future G-BA studies and, ultimately, widespread access for epilepsy patients in need.

Furthermore, as we redefine outpatient reimbursement codes and evaluation by the Evaluation Committee (Bewertungsausschuss), we're not just advocating for a single technology; we're advocating for a paradigm shift in how epilepsy care is delivered and reimbursed.

On this Epilepsy Day, let's commit to keep on breaking barriers and unlock a brighter future for epilepsy patients worldwide.